Covid-19, FDA and vaccines
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FDA Commissioner Marty Makary announced Thursday that the agency will soon provide clear guidelines to vaccine manufacturers for annually updating their Covid-19 shots.
But the framework has perhaps created as much confusion as clarity. Broadly, the FDA said it will limit approval of Covid-19 vaccines to people 65 and older and to those at risk for severe Covid outcomes, and will require vaccine makers to conduct clinical trials investigating whether the shots benefit healthy adults and children.
"Expert Panels with the FDA" are a series of roundtable discussions to provide an open public discourse on the latest medical and scientific information on several important topics. At this roundtable,
Companies focused on psychedelic medicines traded higher for the second straight session on Tuesday after FDA Commissioner Marty Makary said evaluating the potential of psilocybin, MDMA, and other psychedelics will be a “top priority” under the Trump administration.
In an interview on Friday, FDA Commissioner Marty Makary threw his weight behind psychedelic therapies, noting that patients taking these substances experience significant benefits for various neuropsychiatric conditions.
The U.S. Food and Drug Administration plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65, effectively limiting their availability later this year to older adults and those at risk of developing severe illness,
President Donald Trump’s administration is slated to lay out its approach to Covid vaccination at an event Tuesday that could spell major changes in what is required to get regulatory approval for immunizations.
While sparking excitement among biopharma companies focused on rare and ultrarare indications, experts say FDA Commissioner Marty Makary’s proposal is light on details and raises potential concerns about safety,